Surgical Suturing Latch

ABSTRACT

Suturing systems may comprise a cartridge and a drive unit which are detachable from each other. The cartridge often has a cartridge body, a plurality of jaws, and a cartridge interface. The drive unit has a drive unit body, a linkage, and a drive unit interface which will typically include a latch. A latch input is coupled to the latch so that a movement of the input moves the latch to the released position. The cartridge interface or the drive unit interface includes a channel while the other includes a shaft which is fittingly receivable in the channel. Opposed motions of the input and cartridge during cartridge removal avoid inadvertent detachment during use.

CROSS REFERENCE TO RELATED APPLICATION DATA

The present application claims the benefit under 35 USC 119(e) of U.S.Provisional Application No. 61/145,390 filed Jan. 16, 2009; the fulldisclosure of which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

The present invention generally relates to medical devices, systems, andmethods. In specific embodiments, the invention provides devices,systems, and methods for suturing tissues in open surgery, minimallyinvasive surgical procedures, and the like. In particular, manyembodiments of the invention provide suturing systems and devices whichhave parts that are removable from each other.

Although many aspects of surgery have changed radically over the lastseveral decades, some surgical techniques have remained remarkablyconstant. For example, as was true fifty years ago, suturing remains acommon technique for approximation of tissues, ligation of tissues,affixing tissues together, and the like.

Suture has been used in open surgical procedures for generations totherapeutically treat diseased tissue and to close surgical access sitesand other wounds. More recently, the use of minimally invasive surgicaltechniques has expanded, with surgical therapies often being performedat internal surgical sites. Although a wide variety of visualizationtechniques (including laparoscopes and other endoscopic viewing devices,fluoroscopy and other remote imaging modalities, and the like) have beendeveloped to allow surgeons to view these internal surgical sites, andalthough a large variety of new tissue treatment techniques have beendeveloped (including ultrasound techniques, electrosurgical techniques,cryosurgical techniques, and the like) and are now widely available,many modern surgical interventions continue to rely on suturing.

A wide variety of alternatives to suturing of tissues have beendeveloped, and have gained varying degrees of acceptance in certainsurgical procedures. Staples and tissue adhesives are used quitefrequently in many open and minimally invasive surgical settings, and avariety of tissue welding techniques have also been proposed.Nonetheless, suturing remains ubiquitous in surgery, as suturingprovides a number of advantages over many of the alternatives.

Suture's advantages include the large knowledge and skill base thatsurgeons have developed over the years. Additionally, a variety ofoff-the-shelf, pre-packaged surgical needles with suture are availablefrom a large number of suppliers at very reasonable cost. Surgeons areable to precisely control the location of suture stitches by graspingthe suture needle and first pushing it and then pulling it through thetarget tissue. In open surgery, the surgeon may manually grasp thesuture needle directly with his or her hand, although both open andminimally invasive procedures are often performed by grasping the needlewith a needle grasping tool and manipulating the tool to place thesuture stitches. The results obtained using suture are highlypredictable, although dependent on the skill of the surgeon. In light ofits advantages, the use of suture does not appear likely to disappearany time soon, with even modem robotic surgical techniques often makinguse of suture.

Although suture remains popular in surgery at least in part due to itssignificant advantages, suturing is not without disadvantages. Inparticular, placing a large number of suture stitches can be tiring andquite time-consuming. Manipulation of a suture needle can be difficulteven in open surgery due to the limited space that is often availablearound the target tissues. The challenges of manipulating suture needlesmay be even greater in minimally invasive surgical procedures, where theneedles are often manipulated using long-handled tools extending througha small aperture, typically while viewing the procedure on a displaywhich is offset from the surgical site. Tying knots with a desiredamount of tension and the like may call for intricate and precisemanipulation of the suture, further complicating and delaying open andminimally-invasive surgeries. In fact, the time spent closing/suturingthe access site may be significantly greater than the time spenttreating the underlying target tissues for many procedures.Additionally, repeated needle manipulations associated with stitches andknot tying may increase the needle stick risk—an inadvertent needlepuncture to the surgeon or other member of the surgical team. Suchneedle sticks can increase the risk of infection to the surgical staffand patient.

There have been a variety of proposals for modifications to standardsurgical suturing structures and methods to try to address the abovedisadvantages. At least some of these proposals may seek to rely onspecialized and/or proprietary suturing needle systems, which couldincrease costs and preclude their wide acceptance, especially in thirdworld countries. Unfortunately, many proposals for modifying existingsuturing techniques may also decrease the surgeon's control over theplacement of the suture, such as by relying on an automated or indirectmechanical movement of a device to drive a suture needle into and/orthrough tissues. While these new proposals have in the past or may inthe future gain varying degrees of acceptance in one or more surgicalprocedures, standard suturing techniques continue to predominatethroughout surgery in general.

In light of the above, it would be desirable to provide improvedsuturing devices, systems, and methods. It would be generally desirableto maintain some, most, or all of the advantages of standard suturingtechniques, preferably while decreasing the time required for suturing,the strain on the surgeon, the needle stick risk, the training involvedin achieving competence or time-efficiency in suturing techniques, orthe like. It would be particularly advantageous if these improvementscould be provided without requiring extensive capital investments fornew equipment, without significant increases in complexity of thesuturing process, or without having to resort to specialized orproprietary suturing needles and the like. Such suturing systems wouldbe particularly beneficial if they were configured to maintain or evenenhance the sterile surgical field, the components ideally beingconfigured for safe and cost effective sterilization techniques withoutdegrading their ease of use, without excessive risk of inadvertentsystem malfunction during a surgical procedure, and while reducing therisk of the surgeon or operator of being pricked by a suturing needle.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention provide improved suturing systemsand methods that maintain some or all of the advantages of standard openand/or minimally invasive suturing techniques while providing enhancedspeed, ease of use, convenience, reduced disease transmission risk, andease of cleaning and sterilization. Exemplary suturing systems of thepresent invention will generally include a cartridge and a drive unit.The cartridge has a cartridge body, a plurality of needle grasping jaws,and a cartridge interface. The drive unit has a drive unit body, alinkage, and a drive unit interface. The drive unit interface and/or thecartridge interface will often include a latch that can hold thecartridge interface in engagement with the drive unit interface, and areleased position for releasing the cartridge from the drive unit. Alatch input is coupled to the latch so that a movement of the inputmoves the latch to the released position. The interfaces can beconfigured so that removal of the cartridge from the drive unit involvestwo opposed motions relative to the drive unit, such as pressing theinput along a first direction while simultaneously pulling the cartridgeaway from the drive unit in a second direction substantially opposed tothe first direction. Alternative cartridge embodiments may be removed bysimultaneously pressing opposed inputs on the sides of the cartridgetoward each other while pulling the cartridge away from the drive unit,or the like. Preferably, the cartridge interface or the drive unitinterface includes a channel and the other includes a shaft which isfittingly receivable in the channel. The input may be mounted to theshaft so that the input is accessible beyond the channel of thecartridge body.

In a first aspect, the invention provides a suturing system for use witha needle. The suturing system comprises a cartridge and a drive unit.The cartridge has a cartridge body, a plurality of jaws, and a cartridgeinterface. The drive unit has a drive unit body, a linkage, and a driveunit interface. The cartridge interface is removably mountable to thedrive unit interface. Cycling of the linkage effects alternatinggrasping of the needle by the jaws when the drive unit interface engagesthe cartridge interface and the needle is positioned for use. The driveunit interface or the cartridge interface includes a latch. The latchhas at least two positions: a latched position maintaining the cartridgeinterface in engagement with the drive unit interface, and a releasedposition releasing the cartridge from the drive unit. A latch input iscoupled to the latch so that two opposed motions (each comprising amotion relative to the drive unit body) effect movement of the latch tothe released position and removal of the cartridge from the drive unit.

In many embodiments, it is the drive unit interface which includes thelatch. The cartridge interface is removable from the drive unitinterface along a removal orientation, and the latch input is oftencoupled to the latch so that a movement of the input moves the latch tothe released position. The movement of the input is along a mountingorientation so that removal of a latched drive unit involves opposedmotions, relative to the drive unit body, of the input and cartridge.

Typically, the cartridge interface or the drive unit interface includesa channel and the other includes a shaft and a column, the columnsupporting and axially receiving a portion of the shaft. The channelaxially receives the shaft and/or the column along the mountingorientation. Movement of the cartridge along the mounting orientationeffects movement of the latch to the latched position. The jaws may beincluded in a clamping assembly that reciprocates along an associatedjaw reciprocation axis during cycling of the linkage. The jawreciprocation axes are disposed transverse to the mounting orientation,e.g., jaw reciprocation axes are orthogonal or oblique to the mountingorientation. The shaft and the column may be included in the drive unitinterface, and the channel may be included in the cartridge interfacewith the channel extending through the cartridge body, and the input maybe mounted to the shaft so that the input is accessible beyond thechannel of the cartridge body.

In many embodiments, the latch is included in an interface assembly thatis detachably mounted to the drive unit body. This facilitatessterilization and/or replacement of the interface assembly independentlyof at least a portion of the linkage.

In another aspect, embodiments of the invention provide a suturingsystem for use with a needle. The suturing system comprises a cartridgeand a drive unit. The cartridge has a cartridge body, a plurality ofjaws, and a cartridge interface including a channel through thecartridge body. The drive unit has a drive unit body, a linkage, and adrive unit interface including a latch and a shaft assembly fittinglyreceivable within the channel along a mounting orientation. Cycling ofthe linkage effects alternating grasping of the needle by the jaws whenthe drive unit interface engages the cartridge interface and the needleis positioned for use. The latch has a latched position maintaining thecartridge interface in engagement with the drive unit interface, and areleased position releasing the cartridge from the drive unit. A latchinput extends along the shaft assembly of the drive unit interface sothat the latch input is accessible through the channel of the cartridgeand so that articulation of the input transmits motion along the shaftto the latch.

In another aspect, embodiments of the invention provide a suturing driveunit for use with a needle in needle suturing system, the suturingsystem including a cartridge having a cartridge body, a plurality ofjaws, and a cartridge. The suturing drive unit comprises a drive unithaving a drive unit body, a linkage, and a drive unit interface. Thedrive unit interface includes a latch. The cartridge interface isremovable from the drive unit interface along a removal orientation.Cycling of the linkage effecting alternates grasping of the needle bythe jaws when the drive unit interface engages the cartridge interfaceand the needle is positioned for use. The latch has a latched positionmaintaining the cartridge interface in engagement with the drive unitinterface and a released position releasing the cartridge from the driveunit. A latch input is coupled to the latch so that a movement of theinput moves the latch to the released position. The movement of theinput is along a mounting orientation so that removal of a latched driveunit involves opposed motions, relative to the drive unit body, of theinput and cartridge.

The cartridge may include a channel through the cartridge body. Thedrive unit interface may include a shaft fittingly receivable in thechannel along the mounting orientation. The input may be mounted to theshaft so that the input is accessible beyond the channel of thecartridge body. The drive unit interface may further include a columnsupporting and axially receiving a portion of the shaft.

In many embodiments, the latch is included in a latch mechanism. Thelatch mechanism engages the drive unit interface as the drive unitadvances along the mounting orientation so as to effect movement of thelatch to the latched position in response to movement of the cartridgerelative to the drive unit.

The latch may be included in an interface assembly that is detachablymounted to the drive unit body. Having a detachably mounted interfaceassembly facilitates sterilization and/or replacement of the interfaceassembly independently of at least a portion of the linkage.

In another aspect, embodiments of the invention may provide a suturingcartridge for use with a needle in a suturing system, the suturingsystem includes a drive unit having a linkage, a drive unit interfaceincluding a latch, and a shaft assembly with an input. The cartridgecomprises a cartridge body, a plurality of jaws, and a cartridgeinterface. The plurality of jaws is supported by the cartridge body sothat cycling of the linkage effects alternating grasping of the needleby the jaws when the cartridge is mounted to the drive unit and theneedle is positioned for use. The cartridge interface includes a channeland a latch receiving surface. The channel fittingly receives the shaftassembly along a mounting orientation. The latch receiving surface isengageable by the latch so as to restrain the cartridge interface inengagement with the drive unit interface, and so that actuation of theinput is transmitted through the channel so as to release the cartridgefrom the drive unit.

Movement of the cartridge along the mounting orientation can effectmovement of the latching surface to the latched position.

The jaws may each be included in a clamping assembly that reciprocatesalong an associated jaw reciprocation axis during cycling of thelinkage. The jaw reciprocation axes are disposed transverse to themounting orientation.

The input may be mounted to the shaft so that the input is accessiblebeyond the channel of the cartridge interface.

In another aspect, embodiments of the invention may provide a method forsuturing. A cartridge is mounted to a drive unit along a mountingorientation. The cartridge is latched onto the drive unit. A needle isgrasped with a first jaw of the cartridge. A linkage of the drive unitis cycled so as to alternatingly grasp the needle with the first jaw anda second jaw of the cartridge. The cartridge is detached from the driveunit by pushing a latch input of the drive unit along the mountingorientation. The cartridge is moved away from the drive unit along aremoval orientation opposing the mounting orientation.

To mount the cartridge, a shaft of the drive unit may be fittinglyinserted into a channel of the cartridge until a latch mechanism moves alatch to a latched position, restraining an interface of the cartridgeagainst an interface of the drive unit. The input may be mounted to theshaft so that the input is accessible beyond the channel of thecartridge body, and so that the pushing of the input transmits movementalong the shaft to move the latch to a released position. An interfaceassembly may be detached from a drive unit body and the linkage of thedrive unit to facilitate sterilization and/or replacement of theinterface assembly independently of at least a portion of the linkage.The interface assembly may include the latch mechanism.

In many embodiments, the jaws are reciprocated along an axis transverserelative to the mounting orientation so that, when not grasping theneedle, the jaws are free of tissue. The jaws alternatingly grasp aproximal portion of the needle so as to allow the needle to be inserteddistally into a tissue, and a distal portion of the needle so as toallow the needle to be pulled distally from the tissue.

In yet another aspect, the invention provides a suturing system for usewith a needle. The suturing system comprises a cartridge unit having acartridge unit body, a plurality of jaws, and a cartridge unitinterface. A drive unit has a drive unit body, an articulatable handle,a linkage, and a drive unit interface. The cartridge unit interface isremovably mountable to the drive unit interface so that cycling of thearticulatable handle cycles the linkage and the linkage effectsalternating grasping of the needle by the jaws when the drive unitinterface engages the cartridge unit interface and the needle ispositioned for use. A fixed handle surface extends continuously alongthe drive unit body beyond the interfaces and onto the cartridge. Thehandle surface is configured for ergonomic grasping by a hand of theuser while the hand engages both the cartridge body adjacent the clampassemblies and the drive body. This positioning of the hand allows thefingers of the hand to manipulate the articulatable handle, such thatwhen the user forms a suture stitch in an open surgical environment bymoving the suturing system and articulating the articulatable handlewith the hand no assistance of any other hand is needed. Note thatanother hand may optionally be used when mounting or de-coupling thecartridge from the drive unit. In some embodiments another hand may beemployed when tying a knot or the like, though other embodiments willeffect knot tying and/or forming of a plurality of suture stitches withonly the one hand engaging the suture system and thereby manipulatingthe suture needle and suture.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a perspective view of an exemplary suturing systemaccording to embodiments of the invention;

FIG. 1B shows a side view of the suturing system of FIG. 1A;

FIG. 2 shows a perspective view of an exemplary drive unit of thesuturing system of FIG. 1A;

FIG. 2A shows an exploded view of the drive unit of FIG. 2;

FIG. 3 shows a perspective view of an exemplary cartridge of thesuturing system of FIG. 1A;

FIG. 3A shows a cross-sectional view of the cartridge of FIG. 3;

FIG. 3A1 shows a ball and detent arrangement of the cartridge of FIG. 3;

FIGS. 4A-4E show an exemplary method of removing the cartridge of FIG. 3from the drive unit of FIG. 2;

FIG. 5 shows an exemplary linkage mechanism according to embodiments ofthe invention;

FIGS. 6-9 are perspective views showing use of the device of FIG. 1 tosuture tissue; and

FIGS. 10A-10C are side views schematically illustrating handle surfacesof the drive unit and cartridge configured so as to allow a plurality ofhand grasping positions.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is generally directed to improved medical suturingdevices, systems, and methods. Exemplary embodiments of the inventionprovide improved suturing devices and methods for suturing tissues thatcan significantly increase the speed and ease of suturing, particularlywhen suturing of long incisions or where large numbers of stitches areto be deployed, and that have easily removable parts for ease ofcleaning and sterilization.

The invention should find a wide variety of applications for stitchinganatomical tissues in both humans and animals. Along with endoscopicoperations (for example, in laparoscopy) these structures and methodsmay find use in other areas of surgery where tissues are to be stitched,providing particular advantages for stitching of large incisions byincreasing the ease and speed with which each individual stitch may beplaced, as well as facilitating and expediting the formation of knots inthe suture. The suturing devices and associated methods described hereinmay, for example, be used suture a wide variety of strata of anatomicaltissues, including (but not limited to) subcutaneous layers, fascia, theouter skin, various organs (including the uterus), and the like. Whileexemplary embodiments are set forth below, these suturing devices andmethods may be applicable to a wide variety of suturing operations,including open surgery, large and small cavity procedures, endoscopicprocedures, microsurgeries (including for suturing of veins, arteries,and the like), and many specialized surgeries. Embodiments of thesedevices and methods may be particularly useful for surgeries involvinglong incisions, including plastic surgeries. A wide variety of bloodvessels, including both veins and arteries, may also be stitched usingthe techniques described herein, for formation of anastomoses and thelike. Along with increasing the speed and/or ease of forming surgicalsuture stitches, embodiments of the invention will often maintain thecontrol a doctor has over the placement of the sutures by maintaining afixed relationship between the movements of the doctor's hand and theinsertion and withdrawal of the suturing needle. Hence, among theprocedures which may benefit from the invention are subcuticularperitoneum, fascia closure, and skin closure.

While embodiments of the invention may include (or be used within) apowered or automated system, optionally making use of electromechanicalpower, hydraulic power, or the like (for example, with some embodimentsbeing included within a robotic system), other embodiments may beconfigured for manual manipulation by one or more hands of a surgeon,often without having to resort to complex subsystems or external power.

Many embodiments of the devices described herein will be sterilizable soas to allow repeated use. Embodiments of the devices may also comprisecomponents which are easily removable from each other so as tofacilitate sterilization and cleaning. Sterilization may be effectedusing autoclave techniques, chemical sterilization, irradiation, or thelike, with most or all of the structures of the suturing device beingformed of materials suitable for repeated sterilization (such asstainless steel, other metals and alloys, and the like). In general, thesuturing device may comprise one or more plastics and/or metals commonto surgical devices. Although specialized or proprietary suturingneedles may be employed in some embodiments (for example, needles havingflat gripping surfaces so as to maintain an alignment between the needleand an associated clamp), many embodiments of the suturing device willbe suitable for use with standard off-the-shelf suture needles such asthose packaged with any of a wide variety of permanent or resorbablesuture materials in a hermetically sealed package. Some embodiments ofthe device may even comprise components that are removable anddisposable after use and that may be provided sterilized and in ahermetically sealed package. Other embodiments may employ differentsterilization techniques for one assembly (such as a cartridge) thanthat used for another assembly (such as a handle and drive unit). Thus,the invention may find some of its most immediate applications forfacilitating surgical procedures performed manually in Third Worldcountries, allowing physicians to treat a larger number of patients withgreater ease and safety than can be done using standard suturingtechniques, but without the cost or complexity of recently-proposedautomated suturing systems.

Referring now to FIGS. 1A and 1B, an exemplary suturing system 100comprises a cartridge 130 and a drive unit 160. Cartridge 130 includesthe articulating jaw assemblies 140 which grasp the suture needle duringuse. Typically, cartridge 130 is disposable and can be easily removedfrom drive unit 160 for replacement. Drive unit 160 will typically bereusable. By having cartridge 130 and drive unit 160 removable from eachother, drive unit 160 can avoid any need for sterilization, thusavoiding the associated cost. Also, a new cartridge 130 can be providedfor use with a single patient and then disposed of, thus increasing thecleanliness and safety of the suturing system 100 when used with eachnew patient. Cartridge 130 will typically be sterilized and packagedwithin a hermetically sealed package. Drive unit 160 can be usedmultiple times with a plurality of cartridges 130.

Cartridge 130 comprises clamp or jaw structures 140. Each clamp or jawstructures 140 will typically be removably coupled to drive unit 160, inparticular, to a linkage or linkage mechanism 170 of drive unit 160.Each clamp or jaw structure 140 can be actuated by drive unit 160, forexample, by actuation of handle 162 of drive unit 160 to cycle a linkage170 of drive unit 160. Actuation of clamps such as jaws 140 to suturetissue and linkage mechanisms are described in co-assigned U.S. patentapplication Ser. No. 11/532,032, entitled “Suturing Device, System, andMethod” and filed Sep. 14, 2006, the contents of which are incorporatedin their entirety herein by reference. As cartridge 130 includes a pairof jaw or clamp assemblies, the cartridge may sometimes be referred toas a clamp unit, and the portions of the jaw assemblies associated witheffecting articulation and movement of the jaws may optionally beanalyzed as a portion of the overall drive linkage of the assembleddevice or system 100. The use of differing cartridges or clamp units isdescribed in U.S. application Ser. No. 12/049,545 entitled “ReplaceableTip Suturing Devices” and filed on Mar. 17, 2008; the full disclosure ofwhich is incorporated herein by reference.

FIG. 2 shows a perspective view of drive unit 160. The top cover ofdrive unit 160 is not shown for clarity. Drive unit 160 comprises anarticulatable handle 162, drive unit body 165, linkage or linkagemechanism 170, and drive unit interface 175. Cartridge 130 can becoupled to drive unit 160 through drive unit interface 175. Whencartridge 130 and drive unit 160 are coupled, each clamp or jaw assembly140 is coupled to drive linkage mechanism 170 via corresponding driveinterface surfaces 77 and jaw interface surfaces 79 (see FIGS. 2A and3A). In at least some cases, drive unit 160 may further comprise atoggle 163, and drive unit 160 may comprise a release mechanism withinthe linkage so that pressing toggle 163 laterally (with the specificlateral direction depending on which clamp is grasping the needle) movesa surface of the release mechanism so as to release a latch holding thecurrently grasping jaw assembly in the grasping configuration, as can beunderstood with reference to application Ser. No. 11/532,032. Thisresults in both clamps being opened so that the needle is released, andboth clamps being retracted proximally with drive interface surfaces 77positioned to facilitate the decoupling of clamp or jaw assembly 140from drive linkage mechanism 170 (and hence removal of cartridge 130from drive body 160). After release of the needle and removal ofcartridge 130, the interface surfaces 77 will also remain pre-positionedfor subsequent mounting of either the same cartridge or a differentcartridge, as desired.

Linkage mechanism 170 can be cycled, often by actuation of handle 162relative to drive unit body 165 of drive unit 160 so as to effectalternating grasping and releasing of a suturing needle by clamp or jawstructures 140. Drive unit interface 175 may comprise a shaft assemblyincluding a shaft 230 which facilitates the coupling of cartridge 130with drive unit 160 and its removal therefrom as described below. Theshaft assembly of drive unit interface 175 may also comprise a column235 through which shaft 230 is placed. Column 235 stabilizes shaft 230,generally such that shaft 230 is depressible in one direction, and alsoprovides a stable outer surface to guide the cartridge toward a mountedposition relative to drive unit 160, to engage, position, and helpretain the mounted cartridge relative to the drive unit, and/or thelike. In an embodiment shown by FIG. 2A, drive unit interface 175 maycomprise a drive unit interface assembly. The drive unit interfaceassembly may be attached to drive unit body 165 through screws 232, andcan be easily removed from drive unit body 165 for separate cleaning andsterilization, adjustment, and/or repair.

Referring now to FIGS. 3 and 3A, cartridge 130 comprises a cartridgebody 135 which defines a channel 330. Cartridge 130 can be mounted overdrive unit interface 175, with channel 330 axially receiving shaft 230and column 235 along a mounting orientation shown by mounting axis 430.Clamp or jaw structures 140 comprise a pair of openable-closeable jaws141 and are adapted to reciprocate axially along parallel reciprocationaxes 360, which are transverse to mounting axis 430. Pair of jaws 141will typically open and close as clamp or jaw structures 140reciprocate. Clamp or jaw structures 140 can suture tissue byalternating grasping of a suture needle as described below and inco-assigned U.S. patent application Ser. No. 11/532,032, which had beenpreviously incorporated herein by reference.

It may be advantageous to pre-position jaw assemblies 140 along axes 360before mounting, so as to facilitate alignment of jaw interface surfaces79 with their corresponding drive interface surfaces 77. Toward thatend, a ball and detent arrangement 81 and groove 82, as shown in FIG.3A1, may releasably hold jaw assemblies 140 at an appropriate axialposition for mounting. Alternatively, a spring 83 may bias the jawassemblies 140 to an appropriate mounting position, a lever and detentcan be used, or the like. In some embodiments, the jaw assemblies may bepositioned by simply tilting the cartridge and drive unit so that thejaws are angled upward sufficiently to slide the jaw assembliesproximally during mounting, thereby aligning jaw interface surfaces 79with the released drive interface surfaces 77.

Referring now to FIGS. 4A to 4E, an exemplary mechanism by whichcartridge 130 can be removably coupled to drive unit 160 is described.Cross-sectional views of suturing system 100, including cartridge 130and drive unit 160 are shown. Cartridge 130 comprises a cartridgeinterface surface 145 and includes a channel 330. Drive unit interface175 comprises shaft 230, a latch mechanism 177 coupled to shaft 230, anda spring 187. Latch mechanism 177 can pivot about pivot point 178 andcomprises a latch 180 and a latch input 185. Latch mechanism 177, inparticular, latch 180 of latch mechanism 177, can engage cartridgeinterface surface 145 of cartridge 130 to couple cartridge 130 withdrive unit 160. Latch input 185 couples latch mechanism 177 to shaft 230so that latch mechanism 177 pivots when shaft 230 is depressed. Spring187 biases latch mechanism 177 so that it pivots back to its originalposition when shaft 230 is no longer depressed. Latch 180 will typicallybe angled such that as cartridge 130 is advanced downward along mountingaxis 430 to mount cartridge 130 on drive unit 160, cartridge interfacesurface 145 displaces latch 180 such that latch mechanism 177 pivotswithout the need for shaft 230 to be depressed. Cartridge interfacesurface 145 will typically be hook shaped and further pressing cartridge130 downward will eventually no longer cause cartridge interface surface145 to displace latch 180. Latch mechanism 177 then pivots back to itsoriginal position and latch 180 captures cartridge interface surface145.

FIG. 4A shows suturing system 100 as cartridge 130 is mounted onto driveunit 160. Latch 180 engages with cartridge interface surface 145 byhooking onto cartridge interface surface 145, thereby preventingcartridge 130 along with cartridge interface surface 145 from beingmoved up along mounting axis 430. Spring 187 is biased to maintain latchmechanism 177, including latch 180, in this native, latched position.Shaft 230 extends outside of channel 330.

As shown in FIGS. 4B and 4C, as shaft 230 is depressed, for example, bya finger FI, latch mechanism 177 pivots into a released position fromits latched position. In the released position, latch 180 no longerengages cartridge interface surface 145. This alone will typically notbe sufficient for the cartridge to be disengaged from the drive unit soas to inhibit inadvertent detachment during surgery. In addition todepressing input 230 with finger FI, another force (such as one imposedusing one or more other fingers Fz) may pull cartridge 130 away fromdrive unit 160 in a direction opposed to the mounting orientation,simultaneous with the application of force against the input. As shownin FIG. 4D, cartridge 130 can then be moved up along mounting axis 430in a release orientation to remove cartridge 130 from drive unit 160. Asshown in FIG. 4E, once cartridge 130 is removed and finger FI is nolonger depressing shaft 230, latch mechanism 177 is returned to itslatched position by spring 187.

Although one exemplary mechanism by which cartridge 130 can be removablecoupled to drive unit 160, other latching mechanisms may be usedinstead. For example, cartridge 130 may instead comprise a cartridgeinterface comprising shaft 230 as well as latching mechanism 177, anddrive unit body 165 of drive unit 160 may instead define channel 330 foraxially receiving shaft 230. Also, as can be understood with referenceto FIG. 1A, input 330 may be depressed and cartridge 130 moved using asingle hand, such as by pressing the input with the index finger andgrasping the cartridge body between the thumb and other fingers. Hence,the index (or other input actuating finger) may angle proximally awayfrom cartridge 130 (rather than distally as shown) during mountingand/or de-coupling, and/or the cartridge may be grasped between (forexample) the thumb and middle finger while they extend distally alongand beyond the sides of the cartridge, while they extend proximally, orthe like.

FIG. 5 shows an exemplary drive linkage mechanism 528 by which clamp orjaw structures 140A, 140B can alternatingly grasp a needle to suturetissue. Drive linkage 528 may be used with cartridge 130 and drive unit160 to actuate jaw structures. Drive linkage 528 includes analternatable drive element 530 to alternatingly drive a first clamp orjaw structure 140A and then the other clamp or jaw structure 140B.Additionally, drive mechanism 528 includes an alternating latch oranchor 532 for inhibiting axial movement of the clamp that is notcurrently being driven. Release toggle 163 (see FIG. 2A) may optionallyeffect push against latch or anchor 532 so as to release the needle.Drive linkage 528 further makes use of a channel casing in which amovable tubular shaft 536 slides along its respective jaw reciprocatingaxis. First and second pushers and a cone with a rod 544 are disposedalong a jaw reciprocating axis, while a striker 546 and a stop pin witha spring 548 are disposed off the jaw reciprocating axis. As shown inFIG. 5, an openable-closeable pair of jaws 141A of clamp or jawstructure 140A is grasping a needle 10. Movement of drive element 530can produce axial movement of pin 548 so as to compress its spring, sothe pin stops moving axially. As a result, continuing movement of driveelement 530 does not produce additional movement of shaft 536, butinstead causes the cone within its rod 544 to move within the shaft 536.Further movement of drive element 530 results in axial movement of thepushers, causing the striker 546 to move in alignment with a window inthe shaft 536, and thus allowing the striker 546 to engage andreposition latch 532. Openable-closeable pair of jaws 141B of clamp orjaw structure 140A is also reconfigured to be in a closed position froman open position, thereby grasping needle 10. The reconfigured latch 532inhibits proximal movement of the shaft 536 so that the handle 162 canreturn to an unactuated position and also so that the mechanism is nowconfigured to actuate the other jaw structure 140B. The process can berepeated for jaw structure 140B to cause it to grasp needle 10. Furtheractuation of handle 162 can similarly cause pair of jaws 141A of clampor jaw structure 140A to open, clamp or jaw structure 140B to axiallyretract and then axially extend, pair of jaws 141B of jaw structure 140Bto close and re-grasp needle 10, repeat the same process for jawstructure 140B, and so forth. Similar drive linkage mechanism aredescribed in co-assigned U.S. patent application Ser. No. 11/532,032,which had been previously incorporated herein by reference.

Referring now to FIGS. 6-9, the use of suturing system 100 for suturingan incision I in tissue T can be understood. Needle 10 is supported by afirst clamp 140A, with the first clamp 140A grasping a proximal portionof the needle adjacent a suture S. The second clamp 140B is retractedproximally away from needle 1, so that a distal portion of the needle isfree and exposed.

As can be understood with reference to FIG. 6, the surgeon manuallymoves suturing system so as to insert a distal portion of suturingneedle 10 through tissue T. Advantageously, the relative movement ofneedle 10 relative to cartridge 130 and drive unit 160 is inhibited.This allows the surgeon to precisely control movement of the needle 10as it is inserted through the tissue, in a manner analogous to manualmanipulation of the needle using a standard needle grasper or forceps.As can be understood with reference to FIGS. 7 and 8, once the distalportion of needle 10 extends sufficiently through the tissue, clamp orjaw structures 140A and 140B can be cycled through at least a portion oftheir actuation cycle. Through the linkage mechanism 170, second clampor jaw structure 140B is extended distally from the body of suturingsystem 100, and pair of jaws 141B of clamp or jaw structure 140B graspsthe distal portion of needle 10. The first clamp or jaw structure 140Athen releases needle 10 and is withdrawn proximally from around theneedle 10, as illustrated in FIGS. 8 and 9.

As can be understood with reference to FIG. 9, once needle 10 is held bypair of jaws 141B of clamp or jaw structure 140B, the surgeon can againmanipulate the needle 10. The surgeon can move drive unit body 165 andclamp 140B to pull the proximal portion of needle 10 through tissue T,thereby leaving suture S inserted across the incision.

Prior to initiating a second stitch, the surgeon can cycle clamps or jawmechanism 140A, 140B by opening and/or closing handle 162 through a fullactuation cycle. This results in grasping of the needle 10 by first pairof jaws 141A and release of the needle 10 by second pair of jaws 141B,exposing the distal portion of the needle 10 and displacing the secondclamp 140B from the needle 10 so that the needle 10 is ready to againinsert through tissue T. The process can then be repeated without everhaving to completely release needle 10, and by simply actuation ofhandle 162 after insertion of the distal portion of the needle 10through the tissue T and again after each pulling of the needle 10 free.The process is repeated to form as many stitches as is desired.Analogous insertion of the distal portion of the needle through loops ofsuture, actuation of the handle, and pulling the needle free can be usedto quickly and easily form knots.

As can be understood from the illustrations in FIGS. 6-9 and asdescribed above, clamps or jaw mechanisms 140A and 140B extend distallyfrom cartridge 130 and drive unit 160. Clamps or jaw mechanism 140A and140B may move slightly during the actuation cycle, for example, with aclamp or jaw structure initially holding needle 10 retracting slightlyas the other shaft extends, and/or with the grasping jaw structureextending slightly beyond the needle location so that a back surface ofthe jaws engage and stress the needle slightly to compensate for anyslight misalignment. Nonetheless, each clamp or jaw structure holds theneedle 10 at a fixed location while the surgeon holds the handle andinserts or withdraws the needle 10 into or from the tissue. Suturingsystem 100 may also be used in other ways to suture an incision intissue, for example, as described in co-assigned U.S. patent applicationSer. No. 11/532,032, which had been previously incorporated herein byreference.

Referring now to FIGS. 10A-10C, an exemplary ergonomic handle systemsupporting a plurality of hand positions is shown. System 100 generallyincludes a fixed handle surface 602 that extends across the engagedinterfaces of drive unit 160 and cartridge 130, so that a portion of thehandle surface 604 is disposed on the cartridge body, and anotherportion of the handle surface 608 is disposed on the drive unit body.Fixed handle surface 602 may be engaged by the palm and/or thumb of thehand H of the user, with the user typically using some or all of theother fingers to engage and articulate handle 162 relative to the fixedhandle surface.

As can be understood with reference to FIG. 10B, the hand may optionallybe disposed somewhat proximally along the fixed handle surface, so thatsome or all of the fingers of the hand engage a first portion of thearticulatable handle. In the exemplary embodiment, some or all of thefingers of the hand in this proximal position extend through a loop 610of the handle 162. Alternatively, the hand may be positioned moredistally (and closer to jaws 140) as illustrated in FIG. 10C, with someor all of the fingers engaging another portion of handle 162. In theexemplary embodiment some or all of the fingers engage a locally widenedsurface of handle 162 distally of loop 610 when the hand is in thisdistal position. By having the fixed handle surface extend across theinterfaces and onto the cartridge, the user has the option of graspingsuture system 100 as near as possible to the needle, which may beappropriate for fine suturing. In fact, rather than having surfaceswhich bulge out from around the cartridge, the cartridge body mayoptionally be faired smoothly from the interface to its distal end,thereby presenting a more distal fixed grasping surface. Also, while aslight concave proximal region is shown for engaging the hand in theproximal position, fixed handle surface 602 may be smoothly convex alongits length for ergonomic grasping by a hand throughout a range of handpositions. Note that the distal hand position places a portion of thehand quite near the reciprocating shafts of the jaw assemblies, so thatsuch a hand position may be more appropriate for open surgical suturingthan for laparoscopic or other endoscopic applications. Leverage may begreater at the proximal hand position, which may ease cycling of handle162 when placing large numbers of stitches, when manipulating largerneedles, or the like.

While exemplary embodiments of the invention have been described indetail, by way of example and for clarity of understanding, a variety ofmodifications, changes, and adaptations will be obvious to those ofskill in the art. Therefore, the scope of the present invention islimited solely by the appended claims.

1. A suturing system for use with a needle, the suturing systemcomprising: a cartridge having a cartridge body, a plurality of jaws,and a cartridge interface; a drive unit having a drive unit body, alinkage, and a drive unit interface, the cartridge interface removablymountable to the drive unit interface, cycling of the linkage effectingalternating grasping of the needle by the jaws when the drive unitinterface engages the cartridge interface and the needle is positionedfor use; the drive unit interface or the cartridge interface comprisinga latch having a latched position maintaining the cartridge interface inengagement with the drive unit interface and a released positionreleasing the cartridge from the drive unit; and a latch input coupledto the latch so that two opposed motions, each relative to the driveunit body, effect movement of the latch to the released position andremoval of the cartridge from the drive unit.
 2. The suturing system ofclaim 1, wherein the cartridge interface is removable from the driveunit interface along a removal orientation, and wherein the latch inputis coupled to the latch so that a movement of the input along a mountingorientation moves the latch to the released position, the mountingorientation opposing the removal orientation so that removal of alatched drive unit involves opposed motions of the input and thecartridge.
 3. The suturing system of claim 2, wherein the cartridgeinterface or the drive unit interface includes a channel and the otherincludes a shaft and a column, the channel axially receiving the columnalong the mounting orientation.
 4. The suturing system of claim 3,wherein movement of the cartridge along the mounting orientation effectsmovement of the latching surface to the latched position as thecartridge interface engages the drive unit interface.
 5. The suturingsystem of claim 4, wherein the jaws are each included in a clampingassembly that reciprocates along an associated jaw reciprocation axisduring cycling of the linkage, wherein the jaw reciprocation axes aredisposed transverse to the mounting orientation.
 6. The suturing systemof claim 4, wherein the input comprises a shaft, wherein the shaft andthe column are included in the drive unit interface, the columnsupporting and axially receiving a portion of the shaft, and wherein thechannel is included in the cartridge interface with the channelextending through the cartridge body so that the input is accessiblebeyond the channel of the cartridge body.
 7. The suturing system ofclaim 1, wherein the latch is included in an interface assemblydetachably mounted to the drive unit body to facilitate sterilizationand/or replacement of the interface assembly independently of at least aportion of the linkage.
 8. A suturing system for use with a needle, thesuturing system comprising: a cartridge unit having a cartridge unitbody, a plurality of jaws, and a cartridge unit interface; a drive unithaving a drive unit body, a linkage, and a drive unit interfaceincluding a latch, the cartridge unit interface removable from the driveunit interface along a removal orientation, cycling of the linkageeffecting alternating grasping of the needle by the jaws when the driveunit interface engages the cartridge unit interface and the needle ispositioned for use; the latch having a latched position maintaining thecartridge unit interface in engagement with the drive unit interface anda released position releasing the cartridge unit from the drive unit;and a latch input coupled to the latch so that a movement of the inputmoves the latch to the released position, the movement of the inputbeing along a mounting orientation so that removal of a latched driveunit involves opposed motions, relative to the drive unit body, of theinput and clamp unit.
 9. A suturing system for use with a needle, thesuturing system comprising: a cartridge having a cartridge body, aplurality of jaws, and a cartridge interface including a channel throughthe cartridge body; a drive unit having a drive unit body, a linkage,and a drive unit interface including a latch and a shaft assemblyfittingly receivable within the channel along a mounting orientation,cycling of the linkage effecting alternating grasping of the needle bythe jaws when the drive unit interface engages the cartridge interfaceand the needle is positioned for use; the latch having a latchedposition maintaining the cartridge interface in engagement with thedrive unit interface and a released position releasing the cartridgefrom the drive unit; and a latch input extending along the shaftassembly of the drive unit interface so that the latch input isaccessible through the channel of the cartridge and so that articulationof the input transmits motion along the shaft assembly to the latch. 10.A suturing drive unit for use with a needle in needle suturing system,the suturing system including a cartridge having a cartridge body, aplurality of jaws, and a cartridge interface; the suturing drive unitcomprising: a drive unit having a drive unit body, a linkage, and adrive unit interface including a latch, the cartridge interfaceremovable from the drive unit interface along a removal orientation,cycling of the linkage effecting alternating grasping of the needle bythe jaws when the drive unit interface engages the cartridge interfaceand the needle is positioned for use; the latch having a latchedposition maintaining the cartridge interface in engagement with thedrive unit interface and a released position releasing the cartridgefrom the drive unit; and a latch input coupled to the latch so that amovement of the input moves the latch to the released position, themovement of the input being along a mounting orientation so that removalof a latched drive unit involves opposed motions, relative to the driveunit body, of the input and cartridge.
 11. The suturing drive unit ofclaim 10, the cartridge including a channel through the cartridge body,wherein the drive unit interface includes a shaft fittingly receivablein the channel along the mounting orientation, the input being mountedto the shaft so that the input is accessible beyond the channel of thecartridge body.
 12. The suturing drive unit of claim 11, wherein thedrive unit interface further includes a column supporting and axiallyreceiving a portion of the shaft.
 13. The suturing drive unit of claim10, wherein the latch is included in a latch mechanism, the latchmechanism engaging the drive unit interface as the drive unit advancesalong the mounting orientation so as to effect movement of the latch tothe latched position in response to movement of the cartridge relativeto the drive unit.
 14. The suturing drive unit of claim 10, wherein thelatch is included in an interface assembly detachably mounted to thedrive unit body to facilitate sterilization and/or replacement of theinterface assembly independently of at least a portion of the linkage.15. A suturing cartridge for use with a needle in a suturing system, thesuturing system including a drive unit having a linkage and a drive unitinterface including a latch and a shaft assembly including an input, thecartridge comprising: a cartridge body; a plurality of jaws supported bythe cartridge body so that cycling of the linkage effects alternatinggrasping of the needle by the jaws when the cartridge is mounted to thedrive unit and the needle is positioned for use; and a cartridgeinterface including a channel, the channel fittingly receiving the shaftassembly along a mounting orientation, and a latch receiving surfaceengageable by the latch so as to restrain the cartridge interface inengagement with the drive unit interface, and so that actuation of theinput is transmitted through the channel so as to release the cartridgefrom the drive unit.
 16. The suturing cartridge of claim 15, whereinmovement of the cartridge along the mounting orientation effectsmovement of the latching surface to the latched position.
 17. Thesuturing cartridge of claim 15, wherein the jaws are each included in aclamping assembly that reciprocates along an associated jawreciprocation axis during cycling of the linkage, wherein the jawreciprocation axes are disposed transverse to the mounting orientation.18. The suturing cartridge of claim 15, wherein the input is mounted tothe shaft so that the input is accessible beyond the channel of thecartridge interface.
 19. A suturing method comprising: mounting acartridge to a drive unit along a mounting orientation; latching thecartridge onto the drive unit; grasping a needle with a first jaw of thecartridge; cycling a linkage of the drive unit so as to alternatinglygrasp the needle with the first jaw and a second jaw of the cartridge;and detaching the cartridge from the drive unit by pushing at least onelatch input and moving the cartridge away from the drive unit usingmotions along two opposing orientation.
 20. The suturing method of claim16, wherein mounting the cartridge comprises fittingly inserting a shaftof the drive unit into a channel of the cartridge until a latchmechanism moves a latch to a latched position restraining an interfaceof the cartridge against an interface of the drive unit.
 21. Thesuturing method of claim 17, further comprising advancing the inputmounted to the shaft through the channel so that the input is accessiblebeyond the channel of the cartridge body, and so that the pushing of theinput transmits movement along the shaft to move the latch to a releasedposition.
 22. The suturing method of claim 17, further comprisingdetaching an interface assembly from a drive unit body and the linkageof the drive unit to facilitate sterilization and/or replacement of theinterface assembly independently of at least a portion of the linkage,the interface assembly including the latch mechanism.
 23. The suturingmethod of claim 16, further comprising reciprocating the jaws along anaxis transverse relative to the mounting orientation so that, when notgrasping the needle, the jaws are free of tissue, and wherein the jawsalternatingly grasp a proximal portion of the needle so as to allow aneedle to be inserted distally into a tissue, and a distal portion ofthe needle so as to allow the needle to be pulled distally from thetissue.
 24. A suturing system for use with a needle, the suturing systemcomprising: a cartridge unit having a cartridge unit body, a pluralityof jaws, and a cartridge unit interface; a drive unit having a driveunit body, an articulatable handle, a linkage, and a drive unitinterface, the cartridge unit interface removably mountable to the driveunit interface so that cycling of the articulatable handle cycles thelinkage and effects alternating grasping of the needle by the jaws whenthe drive unit interface engages the cartridge unit interface and theneedle is positioned for use; and wherein a fixed handle surface extendscontinuously along the drive unit body beyond the interfaces and ontothe cartridge, the handle surface configured for ergonomic grasping by ahand of the user while the hand engages the cartridge body adjacent theclamp assemblies and the drive body, and while fingers of the handmanipulate the articulatable handle, such that the user forms a suturestitch in an open surgical environment by moving the suturing system andarticulating the articulatable handle with the hand and withoutassistance of any other hand.